Insmed Incorporated

Welcome to the INSMED four-quarter and full-year 2021 financial results. My name is Juan, and I will be coordinating your call today. If you would like to ask a question during the presentation, you may do so by pressing star 1 on your telephone keypad. I will now hand over to your host, Eleanor Bereser, Investor Relations at INSMED, to begin with. Please, Eleanor, go ahead.

Thank you, Juan. Good morning and welcome to today's conference call to discuss our full year financial results for 2021 and to provide a business and pipeline update. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations. Such statements represent our judgment as of today and may involve risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements. Please refer to our filings with the Securities and Exchange Commission, which are available through the SEC's website at www.sec.gov or from our website for information concerning the risk factors that could affect the company. The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining me on today's call are members of the Internet Executive Management Team, including Will Lewis, Chair and Chief Executive Officer, Dr. Martina Flammer, Chief Medical Officer, Roger Asset, Chief Operating Officer, and Sarah Bonsdien, Chief Financial Officer. Let me now turn the call over to Will Lewis for prepared remarks. Upon completion of those remarks, we will open the call up for your questions.

Thank you, Eleanor, and good morning, everyone. Today is a very exciting day for us at INSMED. We are going to share with you a robust set of updates that will clarify how we are thinking about our program catalysts, commercial franchise, and capital allocation over the next several years to support our mission of transforming the lives of patients with serious and rare diseases. At Intamed, we are building what we believe is one of the few companies in our industry capable of producing potentially multi-billion dollars of revenue by the end of this decade. During the course of today's call, we are excited to review the path we will be following as we pursue this ambitious goal. Our strategy is centered on developing medicines that have a significant positive impact on patients' lives. Today, Insomed has seven ongoing mid- and late-stage clinical trials, commercial operations in three territories around the globe, and a research engine working behind the scenes to identify the most promising early-stage candidates by harnessing innovative technologies. We have segmented all of this work into four pillars. The first of these pillars is the Ericase franchise, our marketed product for the treatment of refractory MAC lung disease, where we benefit from a commercial footprint in the US, Europe, and Japan. As these launches mature, we intend to grow revenue globally by at least 30% this year compared to 2021. In parallel, our frontline clinical trial program is advancing to support full FDA and select international approvals of Ericase in newly diagnosed NTM patients. This frontline indication represents a multi-fold increase in the addressable opportunity compared to the refractory setting alone. The ARISE study, which is the first of the two studies needed on our path to approval, is currently 50% enrolled, and we anticipate enrollment to be complete this year with top-line data in the first half of next year. We also anticipate the second study, ENCOR, will be fully enrolled next year. For our second pillar, Brenzocatib, our DPP-1 inhibitor, the Aspen trial exploring the potential of treatment of bronchiectasis is now 50% enrolled, ahead of internal projections, and we anticipate it will be fully enrolled by approximately this time next year. There is real enthusiasm for this trial around the world as this rapid rate of enrollment testifies. In addition to Aspen, the Phase II PK-PD study in cystic fibrosis patients is underway, and we anticipate top-line data by the end of this year or early 2023. In line with our strategy to build a portfolio around neutrophil-mediated diseases using our DPP-1 inhibitor, we are excited to report that we have identified the next two potential indications for renzocatin, along with Phase II clinical trial designs for their exploration. You will hear more about these later on today's call. Our third pillar, TPIP, is a specialized proprosenil prodrug formulation with three parallel phase two programs underway, with an initial focus on potential treatments for PAH and PHILD. We will also review those trial designs later on the call. Finally, translational medicine is our fourth pillar. Led by several world-class teams, our research engine is working with exciting new technologies to identify the next round of incidence early stage pipeline candidates in the serious and rare disease space. Within this framework, we intend to generate, on average, one new IND per year. We look forward to hosting a detailed research day in the second half of this year to update you on our progress. Set against the backdrop of one of the more challenging healthcare markets in recent years, I believe Insumet is poised to weather the storm of these turbulent times. Our goals are ambitious, but we have been deliberate in our pursuit, and we have a track record of achieving what we set out to do. The next stage of our growth will depend on advancing more treatments and strategically complementary indications, and from there, building additional therapeutic areas from our fourth pillar to follow the first three pillars. Let's take a moment to consider what we have accomplished. Our global commercial franchise and infrastructure is already built. We benefit from revenue generation from our marketed product. We have two strategically overlapping pivotal stage programs with Brent Sokative and Eric Case Frontline. We have a robust pipeline, a focused research effort to generate impactful medicines in new therapeutic areas, and a strong cash position. InnsMed is on a path to realize this bright future for the benefit of our patients and our shareholders. All of this is overseen by a world-class leadership team with an impressive track record of executing commercial, clinical, and regulatory pathways, who will now review where we stand in greater detail. Let me start that process by turning the call over to Sarah to walk through our financial results.